USV is aleading healthcare company with the following areas of focus: Generics, Active Pharmaceutical Ingredients (APIs) and Biosimilars. 68% of our business is contributed by India Operations and the rest by export of APIs and Generics.
USV is a 48 year old healthcare company which began as a joint venture with USV&P Inc, a subsidiary of Revlon. Product range consists of Generics, Active Pharmaceutical Ingredients and Biotherapeutics that are manufactured in our modern cGMP compliant plants located in India.
Post: Assistant Manager - Corporate Quality Assurance
Job Description:
- Review of all documents received by Corporate Quality Assurance for approval from R&D , Project & plants:
- MFR, BMR, BPR, Change control, deviation, destruction,PVP, Method validation, stability study protocol, CVP, Exibit and executed BPR
- Investigation of international market complaints and response to complaint.
- Implementationof CAPA.
- Technical support to manufactuirng site.
- Vendor evaluation and qualification for ANDA and regulated market.
- Co-ordination with R&D, Plant and regulatory dept.
- Self audit, accompany to customer audit and involvement in authority audit and compliance accordingly.
- Issuance and implementation of key SOP at all locations.
-Packing related SAP/ R3 activities like BOM, Material code creation, Pre specification for US and Europe market,
-Certificates of analysis for semi regulated market , review and preparation as per country specific requirement of Uganda, Nigeria , Ukrain etc
Specific requirement
-Monitoring quality at all LL locations and third party products
- Also In process check and quality system evaluation when visited to third party and P2P products
-Market Complaint investigation
-Vendor evaluation – R/M and P/M
-Vendor audit- R/M
-SOP preparation
-Technology transfer,
-Scale up and process validation at LL/TP
-Preparation of Packaging material specification
-Export (ROW) – Order Execution Form review and implementation of Standard Packing Procedure , based on country requirement and co-ordination with plant and Regulatory dept.
-Secondary Packaging material development
-Review and approval of change parts layout for regulated market like US, Europe
-APQR of critical products for improvement of quality and yield
-Thorough Knowledge of requirements of regulated market and guidelines
-Knowledge of QC data interpretation
Preference to the person graduated from the Indian Institute of Packaging along with above experience.
Candidate Profile:
- Must have experience in quality agreement & vendor questionnaire.
- Must have knowledge of LIMS, SAP/R3.
- Must have knowledge of ANDA filling, US & Europe requirement.
- Must posses knowledge of production & quality control.
Preference to the person graduated from the Indian Institute of Packaging along with above experience.
Additional Information:
Experience: 5-9 years
Location: Mumbai
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA
forward your CV to, hrd@usv.co.in
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